Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial
Korean Journal of Radiology
; : 330-338, 2016.
Article
Dans En
| WPRIM
| ID: wpr-106788
Responsable en Bibliothèque :
WPRO
ABSTRACT
OBJECTIVE:
This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. MATERIALS ANDMETHODS:
Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated.RESULTS:
A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05).CONCLUSION:
Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine.
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
Aorte
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Phénobarbital
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Bénévoles
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Angiographie
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Amélioration d'image
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Produits de contraste
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Vaisseaux coronaires
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Créatinine
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Effets secondaires indésirables des médicaments
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Iode
Type d'étude:
Clinical_trials
langue:
En
Texte intégral:
Korean Journal of Radiology
Année:
2016
Type:
Article